Boston Scientific Corporation

Additional Location(s): N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

About the Role:

Join us at Boston Scientific, where we are advancing patient care through innovative technologies that address a wide range of urological conditions and enable tailored treatment solutions for every life stage.

We are seeking a Principal Software Engineer to lead the development of mobile applications that interface with our sacral neuromodulation medical devices. As both a technical leader and hands-on contributor, you will work across the full software development lifecycle while ensuring compliance with medical device regulatory standards. This role requires deep expertise in application software development, integration with low-power embedded systems including neurostimulators, cross-platform mobile development for Android and iOS, automated test frameworks, and compliant software engineering within regulated medical environments.

Work mode:

At Boston Scientific, we value collaboration and synergy. This particular role follows a fully onsite work model, requiring employees to be present at our Irvine, California office five days per week.

Visa sponsorship:

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Your responsibilities will include:

• Support software architecture, design, development, testing strategies, and risk management activities for mobile medical software applications.
• Lead the full design life cycle process, including requirements specification, design planning, code reviews, and creation of corresponding artifacts.
• Ensure compliance with IEC 62304, FDA regulations, ISO 13485, ISO 14971, and other applicable medical device standards throughout software and firmware development.
• Contribute to mobile application prototyping and user interface development efforts.
• Develop and implement unit and integration testing strategies, as well as design verification protocols.
• Execute software testing, debugging, static analysis, cybersecurity assessments, and verification using tools such as unit testing frameworks, hardware-in-the-loop (HIL) simulations, and automated test environments.
• Provide technical leadership in software design and apply industry best practices for high-quality, maintainable code.
• Promote collaboration, pragmatic decision-making, and cross-functional alignment throughout the development process.
• Ensure compliance with medical device cybersecurity and safety standards, including FDA premarket cybersecurity guidance and IEC 62443.
• Collaborate with hardware and firmware engineers, systems engineers, quality assurance, regulatory affairs, manufacturing, and program management teams to ensure seamless integration.
• Establish and document software development lifecycle (SDLC) artifacts and processes in alignment with internal quality management systems (QMS). Maintain thorough design documentation and traceability matrices to support regulatory submissions.
• Mentor software engineers by guiding best practices in architecture, implementation, and documentation.
• Support regulatory submissions such as 510(k), PMA, or CE Mark by collaborating with quality and regulatory teams.
• Foster a culture of innovation, continuous improvement, and knowledge sharing within the R&D organization.

Required qualifications:

• Bachelor’s degree or higher in Computer Science, Electrical Engineering, Computer Engineering, Software Engineering, or a related technical field.
• Minimum of 5 years of relevant software development experience, or 4 years with an advanced degree in a related discipline.
• At least 3 years of experience developing embedded or application software, preferably in the medical device or other regulated industries.
• Strong understanding of software engineering principles, including object-oriented programming and API design.
• Proficiency in one or more programming languages such as Swift, Java, Dart, C#, or Objective-C.
• Experience with mobile operating systems and platforms, including iOS and Android.
• Familiarity with cross-platform mobile application development frameworks.
• Experience working in regulated environments such as those governed by the FDA is strongly preferred.
• Demonstrated project management and communication skills.
• Ability to work effectively in a collaborative team environment.

Preferred qualifications:

• Knowledge of UI/UX design principles is a plus.
• Experience in cloud backend development and API interfacing with mobile applications.
• Familiarity with risk assessment, cybersecurity principles, and regulatory compliance practices for implantable medical devices and related software systems.
• In-depth knowledge of Bluetooth Low Energy (BLE) stacks and BLE APIs on major mobile platforms.
• Experience integrating BLE-enabled embedded systems with applications on iOS, Android, and Windows.
• Proficiency in PC application development using Microsoft Visual Studio (e.g., C#.NET).
• Practical experience with secure bootloaders, cryptographic protocols, and over-the-air firmware update mechanisms for embedded or implantable devices.

Requisition ID: 609108

Minimum Salary: $ 103700

Maximum Salary: $ 197000

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com--will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen. So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve.

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identify, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.